Back to resultsEffect of Pioglitazone on Insulin Resistance and Atherosclerosis in Renal Allograft Recipients Without Diabetes
Primary Purpose
Kidney Transplantation, Insulin Resistance, Atherosclerosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pioglitazone
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Transplantation focused on measuring Kidney Transplantation, Thiazolidinediones, Insulin Resistance, Atherosclerosis
Eligibility Criteria
Inclusion Criteria:
- Renal allograft recipients were eligible to participate in the study if they were aged ≥ 18 years, had no previous history of organ transplantation and were not currently using steroids or other immunosuppressants.
Exclusion Criteria:
- Diabetes before transplantation
- Severe metabolic or infectious disease
- Hepatic disease
- Congestive heart failure (New York Heart Association II-IV)
- Cadaver donor kidney donor transplantation
- Unstable condition of the transplanted kidney
Sites / Locations
- Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Insulin Resistance and Insulin Secretion
Secondary Outcome Measures
carotid intima-media thickness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00598013
Brief Title
Effect of Pioglitazone on Insulin Resistance and Atherosclerosis in Renal Allograft Recipients Without Diabetes
Official Title
A Randomized Controlled Trial of Pioglitazone on Insulin Resistance, Insulin Secretion and Atherosclerosis in Renal Allograft Recipients Without History of Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to evaluate the effect of pioglitazone treatment on insulin secretion, insulin resistance, and progression of atherosclerosis in renal allograft recipients without preoperative history of diabetes.
Detailed Description
This is a prospective, randomized, open-label study. The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.
After treatment, we estimated insulin sensitivity index for transplantation,first phase and second phase insulin secretion, secretion area under the curve,and carotid intima-media thickness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Insulin Resistance, Atherosclerosis
Keywords
Kidney Transplantation, Thiazolidinediones, Insulin Resistance, Atherosclerosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.
Primary Outcome Measure Information:
Title
Insulin Resistance and Insulin Secretion
Time Frame
1 year
Secondary Outcome Measure Information:
Title
carotid intima-media thickness
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Renal allograft recipients were eligible to participate in the study if they were aged ≥ 18 years, had no previous history of organ transplantation and were not currently using steroids or other immunosuppressants.
Exclusion Criteria:
Diabetes before transplantation
Severe metabolic or infectious disease
Hepatic disease
Congestive heart failure (New York Heart Association II-IV)
Cadaver donor kidney donor transplantation
Unstable condition of the transplanted kidney
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Chul Lee, Doctor
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
32803882
Citation
Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
Results Reference
derived
PubMed Identifier
19875376
Citation
Han SJ, Hur KY, Kim YS, Kang ES, Kim SI, Kim MS, Kwak JY, Kim DJ, Choi SH, Cha BS, Lee HC. Effects of pioglitazone on subclinical atherosclerosis and insulin resistance in nondiabetic renal allograft recipients. Nephrol Dial Transplant. 2010 Mar;25(3):976-84. doi: 10.1093/ndt/gfp567. Epub 2009 Oct 28.
Results Reference
derived
Learn more about this trial
Effect of Pioglitazone on Insulin Resistance and Atherosclerosis in Renal Allograft Recipients Without Diabetes
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